Original New Drug Application Approvals by US FDA (01-15 March 2023)

16 Mar 2023
Original New Drug Application Approvals by US FDA (01-15 March 2023)
New drug applications approved by US FDA as of 01-15 March 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

COMBOGESIC
  • Active Ingredient(s): Acetaminophen; Ibuprofen
  • Strength: 325MG;97.5MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Aft Pharms Ltd
  • Approval Date: 01 March 2023
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated in adults for the short term management of mild to moderate acute pain.
  • Approved Label:  01 March (PDF)
NALOXONE HYDROCHLORIDE
  • Active Ingredient(s): Naloxone Hydrochloride
  • Strength: 4MG/0.25ML
  • Dosage Form(s) / Route(s): Spray;nasal
  • Company: Amphastar Pharms Inc
  • Approval Date: 07 March 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adults and pediatric patients.
    Naloxone Hydrochloride Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
    Naloxone Hydrochloride Nasal Spray is not a substitute for emergency medical care.
  • Approved Label:  07 March (PDF)
ZAVZPRET
  • Active Ingredient(s): Zavegepant
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Spray;nasal
  • Company: Pfizer Inc
  • Approval Date: 09 March 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.

    Limitations of Use
    ZAVZPRET is not indicated for the preventive treatment of migraine.
  • Approved Label:  09 March (PDF)
DAYBUE
  • Active Ingredient(s): Trofinetide
  • Strength: 200MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Acadia Pharms Inc
  • Approval Date: 10 March 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
  • Approved Label:  10 March (PDF)